Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study

Cystic Fibrosis Clinical Trial

— ASSURE  

Official title:

Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750501
• Other study ID #: Protocol 0000498-02
• Status: Completed
• Phase: N/A
• Start date: July 20, 2016
• Est. completion date: March 30, 2017

Study information

• Verified date: June 2018
• Source: Alcresta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB use, in patients with cystic fibrosis and exocrine pancreatic insufficiency.

Description:

Study Entry (Day -14): Baseline blood samples collected for plasma and erythrocyte concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA). Baseline characteristics collected included BMI and cystic fibrosis related diabetes.

Observation Period (Day -14 to Day -8): Subjects followed their usual enteral nutrition regimen with pancreatic enzyme replacement therapy (PERT).

Run-in Period (Day -7 to Day -1): Subjects used Peptamen 1.5 enteral formula at their normal volume of administration from 500 mL to 1,000 mL per feeding with usual PERT regimen.

Treatment Period (Day 0 to Day 90): Subjects used Impact Peptide 1.5 up to a maximum volume of 1,000 mL per feeding with RELiZORB for the 90 day treatment period. Blood screening measurements were repeated at start of treatment period (Day 0), Day 30, Day 60 and Day 90. PERT use with enteral feedings was prohibited. Safety and tolerability were assessed with GI symptom diaries and systematic assessments of adverse events and unanticipated adverse device effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

1. Confirmed diagnosis of cystic fibrosis

2. Documented history of exocrine pancreatic insufficiency

3. Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5

4. Written informed consent or assent.

Exclusion Criteria:

1. Uncontrolled diabetes mellitus

2. Signs and symptoms of liver cirrhosis or portal hypertension

3. Lung or liver transplant

4. Active cancer currently receiving cancer treatment

5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• RELiZORB (immobilized lipase) cartridge
Hydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge

Other:
• Impact Peptide 1.5
Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding

Locations

Country	Name	City	State
United States	St. Luke's CF Center of Idaho	Boise	Idaho
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Dayton Children's Hospital	Dayton	Ohio
United States	Helen DeVos Children's Hospital CF Care Center	Grand Rapids	Michigan
United States	Joe DiMaggio Children's Hospital / Memorial Healthcare System	Hollywood	Florida
United States	Riley Hospital for Children at Indiana University Health	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Cardinal Glennon Children's Hospital / Saint Louis University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Alcresta Therapeutics, Inc.	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GI Symptoms	GI symptoms recorded in GI diaries by subject and/or caregiver.	Observation, Baseline and RELiZORB Treatment periods (Day -14 to Day 90): 104 days with additional 30 days of follow up.
Primary	Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)	Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index	Day 0 to Day 90
Secondary	Unanticipated Adverse Device Effects (UADE)	A UADE is analogous to a serious adverse event (SAE), defined as an AE, occurring at any exposure to the therapeutic agent, that results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant disability or incapacity or a congenital anomaly/birth defect.	RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.
Secondary	Changes in Plasma Concentration Total DHA+EPA	Changes in plasma concentration total DHA+EPA from baseline (Day 0 to Day 90).	RELiZORB Treatment Period (Day 0-Day 90): 90 days
Secondary	Erythrocyte Composition (%) of DHA	Changes over time in erythrocyte composition (%) for total DHA in ITT population (n=39)	RELiZORB Treatment Period (Day 0-Day 90): 90 days
Secondary	Erythrocyte Composition (%) of EPA	Changes over time in erythrocyte composition (%) for EPA in ITT population	RELiZORB Treatment Period (Day 0-Day 90): 90 days
Secondary	Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids	Change from baseline to Day 90 in n6/n3 ratio in erythrocytes	RELiZORB Treatment Period (Day 0-Day 90): 90 days
Secondary	Plasma Composition (%) Ratio of n6/n3 Fatty Acids.	Change over time in n6/n3 ratio in plasma in the ITT population	RELiZORB Treatment Period (Day 0-Day 90): 90 days